Leptomeningeal Metastasis, Lung Cancer
Conditions
Keywords
Leptomeningeal Metastasis, ,Nimotuzumab, Lung Cancer, EGFR-TKI
Brief summary
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.
Interventions
DRUGNimotuzumab
Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks
Sponsors
Hui Bu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or older, gender not limited; * A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging; * Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis * Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage * Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression * Bone marrow, liver, kidneys and blood clotting function are relatively stable
Exclusion criteria
* Eastern Cooperative Oncology Group scored \> 2 points * Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 2 years | From the diagnosis of the LM to the time of disease worsen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | From the diagnosis of theLM to the time of death |
| Incidence of Treatment-Emergent Adverse Events | 8Weeks | When the Nimotuzumab is used,we will observe if the patients have the allergic reaction,diarrhea ,vomiting and so on.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary Contacthui bu, PhD
Backup Contactjiao xue qi, master
Outcome results
None listed